Job Description

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

Job description

We are excited to be named one of the World's Best Workplaces by Fortune Magazine!


We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

What you will do-

P

erform preliminary complaint intake, management, and event classification.

Conduct customer follow-ups and assess complaints for regulatory reportability

in accordance with

FDA 21 CFR 803, EU MDR 2017/745, and ISO 13485.

Prepare and submit MDR, MIR, vigilance, and global adverse event reports, achieving zero late submissions.

Collaborate closely with stakeholders and team members, providing guidance and coaching to drive engagement and performance.

Demonstrate strong knowledge of Post-Market Surveillance requirements (US FDA and EU MDR), Quality Management Systems (ISO 13485, 21 CFR 820), and complaint handling tools such as

TrackWise

or equivalent systems.

Experience with

TrackWise

and Microsoft Project

;

Post Market Surveillance as per US FDA & EU MDR

;

Quality Management (ISO 13485 or 21 CFR 820 ; working with multiple teams and collaborating across geographically spread multi-functional teams.

Understanding on Medical Device Risk Management

What you will need-

Required-

BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes

Experience- 2years to 5 years

1

-

2

years of experience in Medical Device domain;

At least

1

+ years of experience in complaint handling or customer quality.

Preferred-

ISO 13485:2016

certification

Strong analytical and problem-solving skills;

e

xcellent written and verbal communication skills and p

roficiency

in QMS software and tools

.

Able to

run

communicate effectively

with senior leadership

.

Excellent

problem-solving

skills.

Proactive to support both internal and external

customers.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.